Oral care implement

ABSTRACT

An oral care implement comprising tooth cleaning elements and a tissue cleanser. In one aspect, the invention can be an oral care implement comprising: a head and a handle; a plurality of tooth cleaning elements extending from a first face of the head; a receiving cavity formed into a second face of the head opposite the first face; and a soft tissue cleanser formed of an elastomeric material positioned within the receiving cavity, the soft tissue cleanser comprising a base surface that is flush with the second face of the head and a plurality of projections extending beyond the second face of the head.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. patentapplication Ser. No. 13/116,735, filed May 26, 2011, which is acontinuation of U.S. patent application Ser. No. 11/932,010, filed Oct.31, 2007, now U.S. Pat. No. 7,950,100, which is a divisional applicationof U.S. patent application Ser. No. 11/566,479, filed Dec. 4, 2006, nowU.S. Pat. No. 7,322,067, which is a divisional application of U.S.patent application Ser. No. 10/869,922, filed Jun. 18, 2004, now U.S.Pat. No. 7,143,462, which is: (1) a continuation-in-part of U.S. patentapplication Ser. No. 10/601,106, filed Jun. 20, 2003; (2) acontinuation-in-part of PCT patent application Ser. No. PCT/US03/030633filed Sep. 26, 2003 (now expired), which claims the benefit of priorityto U.S. Provisional Application No. 60/414,117, filed Sep. 27, 2002,(now expired), U.S. Provisional Application No. 60/418,776, filed Oct.16, 2002 (now expired) and U.S. patent application Ser. No. 60/419,425,filed Oct. 18, 2002 (now expired); (3) a continuation-in-part of PCTPatent Application No. PCT/US2003/029497, filed Sep. 17, 2003 (nowexpired), which claims the benefit of priority to U.S. Provisionalpatent application Ser. No. 60/412,290, filed Sep. 20, 2002 (nowexpired); and (4) a continuation-in-part of U.S. patent application Ser.No. 29/189,729, filed Sep. 10, 2003, now U.S. Pat. No. D517,812. Thecontents of the above-noted applications are each expressly incorporatedherein by reference.

FIELD OF THE INVENTION

The present invention pertains to an oral care implement with a cleanserfor cleaning soft tissue surfaces in the mouth.

BACKGROUND OF THE INVENTION

According to the American Dental Association, a major source of badbreath in healthy people is microbial deposits on the tongue, where abacterial coating harbors organisms and debris that contribute to badbreath. The tongue is a haven for the growth of microorganisms since thepapillary nature of the tongue surface creates a unique ecological sitethat provides an extremely large surface area, favoring the accumulationof oral bacteria. Anaerobic flora and bacteria residing on the tongueplay an important role in the development of chronic bad breath commonlycalled halitosis. In general, the bacteria produce volatile sulfurcompounds (VSC). If there is enough buildup of the sulfur compounds, theresult can be lead bad breath or oral malodor.

While bladed tongue scrapers have been used in the past, these scrapersare inadequate in respect to their effectiveness on the soft tissuesurface of the tongue. Broad flat scraping blades are limited in theirability to reach between the papillae where the bacteria and microdebrishave collected. Moreover, notwithstanding the benefits to be gained byany ability to clean the tongue, some users avoid the use of such bladesbecause of lack of comfort on the tongue surface.

Hence, there is a need for an oral care implement with a tongue cleanserthat provides effective removal of the tongue bacteria and other debriswhile maintaining comfort to the user.

SUMMARY OF THE INVENTION

The invention pertains to an oral care implement with a tissue cleanserthat provides improved cleaning and effective removal of bacteria andmicrodebris disposed on the oral tissue surfaces.

In one aspect, the invention can be an oral care implement comprising: ahead and a handle; a plurality of tooth cleaning elements extending froma first face of the head; a receiving cavity formed into a second faceof the head opposite the first face; a soft tissue cleanser formed of anelastomeric material that is injection molded into the receiving cavity,the soft tissue cleanser comprising a plurality of projections; and oneor more peg members extending from a lower base surface of the receivingcavity, the soft tissue cleanser comprising one or more complementaryapertures that receive the one or more peg members and expose tops ofthe one or more peg members.

In another aspect, the invention can be an oral care implementcomprising: a head and a handle; a plurality of tooth cleaning elementsextending from a first face of the head; a receiving cavity formed intoa second face of the head opposite the first face; and a soft tissuecleanser formed of an elastomeric material that is injection molded intothe receiving cavity to bond the soft tissue cleanser to the head, thesoft tissue cleanser comprising a plurality of projections extendingbeyond the second face of the head.

In yet another aspect, the invention can be an oral care implementcomprising: a handle; a head having a longitudinal axis; a plurality oftooth cleaning elements extending from a first face of the head; areceiving cavity formed into a second face of the head opposite thefirst face, the receiving cavity comprising a peripheral sidewallextending away from a lower base surface; a soft tissue cleanser formedof an elastomeric material that is injection molded into the receivingcavity to bond the soft tissue cleanser to the head, the soft tissuecleanser comprising a plurality of nubs that extend beyond the secondface of the head; and at least one peg member aligned along thelongitudinal axis and extending from the lower base surface of thereceiving cavity, the soft tissue cleanser comprising at least onecomplementary aperture that exposes a top of the at least one pegmember.

In an even further aspect, the invention can be an oral care implementcomprising: a head and a handle; a plurality of tooth cleaning elementsextending from a first face of the head; a soft tissue cleanser on thehead opposite the first face, the soft tissue cleanser formed of anelastomeric material that is injection molded to the head to bond thesoft tissue cleanser to the head, the soft tissue cleanser comprising aplurality of projections; and at least one peg member aligned along thelongitudinal axis and extending from the head, the soft tissue cleansercomprising at least one complementary aperture that exposes a top of theat least one peg member

Further areas of applicability of the present invention will becomeapparent from the detailed description provided hereinafter. It shouldbe understood that the detailed description and specific examples, whileindicating the preferred embodiment of the invention, are intended forpurposes of illustration only and are not intended to limit the scope ofthe invention.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present invention and theadvantages thereof may be acquired by referring to the followingdescription in consideration of the accompanying drawings, in which likereference numbers indicate like features, and wherein:

FIG. 1 is an exploded assembly perspective view of an oral careimplement according to one or more aspects of an illustrativeembodiment;

FIG. 2 is an enlarged perspective view of a head of an oral careimplement of FIG. 1;

FIG. 3 is a plan view of the oral care implement of FIG. 1 illustratinga tongue cleaning feature;

FIG. 4 is a partial section view of a head of the oral care implement ofFIG. 1 taken along line 4-4 of FIG. 3;

FIG. 5 is a plan view of the oral care implement of FIG. 1 illustratingat least one tooth cleaning configuration;

FIG. 6 is a perspective of the view of the oral care implementillustrating example tooth cleaning elements; and

FIG. 7 is a section view of an alternative construction of the head ofan oral care implement.

DETAILED DESCRIPTION OF THE INVENTION

The following description of the preferred embodiment(s) is merelyexemplary in nature and is in no way intended to limit the invention,its application, or uses.

In the following description, the invention is discussed in terms of atoothbrush, but could be in the form of other oral care implementsincluding simply a tissue cleansing implement. Further, it is to beunderstood that other embodiments may be utilized and structural andfunctional modifications may be made without departing from the scope ofthe present invention.

FIGS. 1-7 illustrate an oral care implement, such as a toothbrush 100,having a handle 103 and a head 105 which may be used for cleaning theteeth and soft tissue in the mouth, such as the tongue, interiorsurfaces of the cheeks, lips or the gums. Handle 103 is provided for theuser to readily grip and manipulate the toothbrush, and may be formed ofmany different shapes and constructions. While the head is normallywidened relative to the neck of the handle, it could in someconstructions simply be a continuous extension or narrowing of thehandle. In the preferred construction, head 105 has a first face 106that supports tooth cleaning elements 107 (FIGS. 5 and 6) and a secondface 108 that supports a tissue cleanser 300 (FIGS. 2 and 3). The firstand second faces 106, 108 are preferably on opposite sides of head 105.Nevertheless, tissue cleanser 300 may be mounted elsewhere, such as theproximal end 104 of handle 103. The tissue cleanser 300 or portions ofit may also be located on the peripheral sidewall surface 101 of head105 or extend farther towards the proximate end 104 of handle 103 thanillustrated.

The elastomeric material of tissue cleanser 300 may be any biocompatibleresilient material suitable for uses in an oral hygiene apparatus. Toprovide optimum comfort as well as cleaning benefits, the elastomericmaterial preferably has a hardness property in the range of A8 to A25Shore hardness. As an example, one preferred elastomeric material isstyrene-ethylene/butylene-styrene block copolymer (SEBS) manufactured byGLS Corporation. Nevertheless, SEBS material from other manufacturers orother materials within and outside the noted hardness range could beused.

Tissue cleanser 300 is preferably configured with a multiplicity oftissue engaging elements 303 (FIGS. 1-4), which in the preferredconstruction are formed as nubs. As used herein a “nub” is generallymeant to include a column-like protrusion (without limitation to thecross-sectional shape of the protrusion) which is upstanding from a basesurface. In a general sense, the nub, in the preferred construction, hasa height that is greater than the width at the base of the nub (asmeasured in the longest direction). Nevertheless, nubs could includeprojections wherein the widths and heights are roughly the same orwherein the heights are somewhat smaller than the base widths. Moreover,in some circumstances (e.g., where the nub tapers to a tip or includes abase portion that narrows to a smaller projection) the base width can besubstantially larger than the height.

Such tissue engaging elements 303 are designed to significantly reduce amajor source of bad breath in people and improve hygiene. Nubs 303enable removal of microflora and other debris from the tongue and othersoft tissue surfaces within the mouth. The tongue, in particular, isprone to develop bacterial coatings that are known to harbor organismsand debris that can contribute to bad breath. This microflora can befound in the recesses between the papillae on most of the tongue's uppersurface as well as along other soft tissue surfaces in the mouth. Whenengaged or otherwise pulled against a tongue surface, for example, nubs303 of elastomeric tissue cleanser 300 provide for gentle engagementwith the soft tissue while reaching downward into the recesses ofadjacent papillae of the tongue. The elastomeric construction of tissuecleanser 300 also enables the base surface 301 to follow the naturalcontours of the oral tissue surfaces, such as the tongue, cheeks, lips,and gums of a user. Moreover, the soft nubs 303 are able to flex asneeded to traverse and clean the soft tissue surfaces in the mouth alongwhich it is moved.

As seen in FIGS. 2 and 4, in one preferred arrangement of tissuecleanser 300, nubs 303 are preferably conically shaped. As used herein,“conically shaped” or “conical” is meant to include true cones,frusto-conically shaped elements, and other shapes that taper to anarrow end and thereby resemble a cone irrespective of whether they areuniform, continuous in their taper, or have rounded cross-sections. Withreference to FIG. 4, the base portion 305 of each conically shapedtissue engaging element 303 is larger than the corresponding tip portion307. In this conically shaped configuration, the base portion 305 has awider cross-sectional area to provide effective shear strength towithstand the lateral movement of the tissue cleanser 300 along thesurface of the tongue or other soft tissue surface. The smaller width ordiameter of the tip portion 307 in conjunction with the length of theconically shaped nub 303 enable the nubs to sweep into the recesses ofthe tongue and other surfaces to clean the microbial deposits and otherdebris from the soft tissue surfaces. In the preferred construction,nubs 303 are able to flex and bend from their respective vertical axesas lateral pressure is applied during use. This flexing enhances thecomfort and cleaning of the soft tissue surfaces. In a preferredconstruction, the thickness or width of the base of the nub in 0.64 mm,and preferably within the range from about 0.51 mm to about 2.00 mm. Tip307 of the nubs is 0.127 mm and preferably within that range from about0.10 mm to about 0.75 mm for optimal penetration between the recesses ofpapillae of a user's tongue. The length or height of nubs 303, asmeasured from base surface 301 to tip 307, is preferably 0.91 mm andpreferably within range from about 0.5 mm to about 2.5 mm, and mostpreferably range between 0.75 mm to 1.5 mm. Nevertheless, nubs of othersizes and shapes outside the given ranges can be used.

Alternatively, the tissue cleaning elements 303 may have other shapes.As one example, the tissue cleanser may have a grated form such asdescribed in co-pending U.S. patent application Ser. No. 10/601,106,incorporated herein by reference.

In a preferred construction, nubs 303 are disposed on the base surface301 of tissue cleanser 300 in a high density pattern. Each nub 303 ispreferably spaced apart from adjacent nubs 303 between a range of about0.5 mm to about 3 mm; more preferably the spacing ranges between 0.7 mmto 2.5 mm, and most preferably between 1 mm to 2 mm. Nevertheless, otherspacing ranges are possible. The surface density of the nubs 303 on basesurface 301 ranges preferably from about 100 to about 600 nubs persquare inch. In a more preferred construction of the tissue cleanser,the surface density may range from 200 to 500 nubs per square inch, andmost preferably between 300 to 450 nubs per square inch. In onepreferred example, tissue cleanser 300 includes about 400 nubs persquare inch of surface area. The surface density features in conjunctionwith the height of the nubs 303 enables the tissue cleanser to provideenhanced cleaning of the soft tissue surfaces with improved comfort.Nonetheless, other surface densities are possible.

As seen in FIG. 3, nubs 303 are preferably disposed in longitudinal rowsin a direction generally parallel to the longitudinal axis a-a. Further,nubs 303 are disposed in transverse rows R1, R2 on an axis parallel tobase surface 301 and generally perpendicular to the longitudinal axisa-a. In one preferred construction, adjacent nubs 303 are provided onthe base surface 301 in a staggered arrangement. For example, adjacenttransverse rows of nubs R1 and R2 have nubs 303 that are not directlybehind each other. A first nub is said herein to be “directly behind”second nub when it is located within the lateral bounds of the secondnub extending in a longitudinal direction. This configuration enablesimproved cleaning of the soft tissue surfaces by facilitating theremoval of microflora and other debris, and especially from the recessesof adjacent papillae of the tongue. Nonetheless, the nubs could bearranged randomly or in a myriad of different patterns.

Tongue cleanser 300 is preferably formed by being molded to head 105,although other manufacturing processes could be used. With reference toFIGS. 1 and 4, tissue cleanser 300 is preferably molded within a basinor a receiving cavity 111 in face 108 of head 105. The receiving cavity111 has a lower base surface 113 and a peripheral sidewall 115 extendingaway from the lower base surface 113. In one mounting arrangement, nubs303 of the tissue cleanser 300 are exposed for use with the base surfaceof the tissue cleanser 300 being flush or recessed relative to thesurface 114 of the head. Nevertheless, other orientations are possible.Also, base surface 301 of the tissue cleanser could be embedded in head105 or covered by another layer with nubs 303 projecting throughappropriate openings.

As can be seen in FIGS. 1 and 4, face 108 also preferably includes oneor more peg members 117 a-c disposed within basin 111. Peg members 117form anchor points against the opposing mold to prevent the head frommoving under the pressure of the injection molding. As a result, tissuecleanser 300 preferably includes one or more complementary apertures 311a-c which exposes the tops of peg members 117 a-c. Although, the pegsare illustrated in alignment along the centerline of the head (e.g.longitudinal axis a-a), the pegs could have many different positions.Further, the pegs and basin are preferably both included with head 105,but either could be used without the other.

Alternatively, basin 111 and peg members 117 a-c may be provided toposition and hold a previously molded tissue cleanser, although theseconstructions are not necessary to use such a previously molded tissuecleanser.

Peg members 117 a-c may take on a variety of shapes and lengths. Withcontinued reference to the FIGS. 1 and 4, head 105 includes peg members117 a-c extending away from the lower base surface 113 of basin 111 tothe height of the peripheral sidewall 115. The peg members 117 a-c areshaped in the form of a cylinder, but other shapes and lengths of thepeg members 117 a-c are possible. While the molding process wouldpreferably bond the tissue cleanser to the head, the tissue cleansercould be preformed and attached by adhesive or other known means.

As shown in FIGS. 1-4, tissue cleanser 300 is preferably formed as a padcomposed of a soft and pliable elastomeric material for comfortablecleaning and effective removal of bacteria and debris disposed on thesurface of the tongue, other soft tissue in the mouth and even along thelips. The tissue cleanser 300 also provides effective massaging,stimulation and removal of bacteria, debris and epithelial cells fromthe surfaces of the tongue, cheeks, gums or lips.

In the preferred construction (FIGS. 1-6), tissue cleansers 300 may rubagainst the inside surfaces of the cheeks or lips, and on the sides ofthe tongue while the user brushes his or her teeth, and thus provide adesired massaging, stimulation and cleaning of various soft tissuesurfaces within the mouth. For example, during brushing of the facialtooth surfaces, tissue cleanser 300 is disposed on the outer face 108 ofhead 105 to naturally rub against the oral surfaces of the cheek. As aresult, enhanced cleaning is attained without additional cleaning steps.Further, some users may sense a stimulating tingle on the cheek surfacesthat leads to a positive user reaction, and even enjoyment of thecomfortable feel of the tissue cleanser along the soft tissues surfacesin the mouth. Tissue cleanser 300 may also be additionally rubbed on thecheeks, tongue, etc. as desired for further cleaning aside from thecontact that may occur while brushing the teeth.

Referring to FIGS. 5 and 6, the tooth cleaning elements 107 of head 105may include a variety of tooth cleaning elements which can be used forwiping, cleaning and massaging the user's teeth and gums. Any suitableform of tooth cleaning elements may be used. The term “tooth cleaningelements” is used in a generic sense which refers to filament bristlesor elastomeric fingers or walls that have any desirable shape. In theillustrated example of FIG. 5, tooth cleaning elements 107 includedistal tooth cleaning elements 203 a-b disposed at a distal tip 121 ofhead 105, peripheral tooth cleaning elements 205 a-l, longitudinal toothcleaning elements 207 a-c disposed along longitudinal axis a-a, arcuatetooth cleaning elements 209 a-d and 211 a-b, and proximal cleaningelements 213 a,b. Tooth cleaning elements 205, 207, 211 and 213 arepreferably provided as tufts of bristles whereas tooth cleaning elements209 are preferably formed as elastomeric walls. Nevertheless, otherforms and types of tooth cleaning elements may be used.

FIG. 7 illustrates a sectional view of an alternative arrangement of ahead 400 of a toothbrush. Head 400 is similar in construction to head105, except that tooth cleaning elements 209 a-d are integrally formedwith tissue cleanser 300. To accomplish the alternative construction,head 400 has appropriately sized ports or openings 401 to allow theelastomeric material to flow through the head during an injectionmolding process. In this construction, tooth cleaning elements 209 a-dand tissue cleaner 300 are formed with the same elastomeric material.Thus, head 400 may include at least one elastomeric tooth cleaningelement formed as a unitary member with tissue cleanser 300.

As various changes could be made in the above methods, compositions andstructures without departing from the scope of the invention, it isintended that all matter contained in this application, including allmechanisms and/or modes of interaction described above, shall beinterpreted as illustrative only and not limiting in any way the scopeof the appended claims.

The following examples are set forth as representative of the improvedoperation of the present invention. These examples are not to beconstrued as limiting the scope of the invention.

EXAMPLE 1

The performance nature of a toothbrush can be measured using known oralmalodor assessment methods. A study was conducted to evaluate theperformance of a toothbrush provided with an elastomeric tissue cleanserhaving conically shaped nubs, such as the preferred construction oftoothbrush 100 discussed above. Human test subjects participated in thestudy. There was a washout or normalization period prior to testing ofabout 7 days in which the test subjects brushed twice a day with afluoride dental cream (see Table 1). After the washout period, the testsubjects were asked to refrain from any oral hygiene (brushing, rinsing,and flossing), eating and drinking prior to oral testing. A baselinevolatile sulfur compound (VSC) sample was taken from each of the testsubjects. In the study for overnight odor control, the test subjectsbrushed their teeth for one minute with a fluoride dental cream (seeTable 1) using toothbrush 100 provided with the above noted tissuecleanser 300. Subsequently, the subjects cleaned their tongue surfacewith the tissue engaging elements of the toothbrush for ten seconds. Thetest subjects slept overnight and returned for post treatment. VSCsamples were taken at the ten-hour time point from the previous daycleaning. In the illustrative example, use of the toothbrush reducedoral VSC about 60% versus brushing the teeth alone as measured from abaseline ten hours after use. The VSC readings were obtained by gaschromatography.

EXAMPLE 2

In another study of the above-noted toothbrush 100, there was a washoutor normalization period prior to testing of about 7 days which the testsubjects brushed twice a day with a fluoride dental cream (see Table 1).The test subjects were asked to refrain from any oral hygiene (brushing,rinsing, and flossing), eating and drinking before testing. After thewashout period, the test subjects provided a baseline tongue bacteriasample by swabbing a side of the back of the tongue with a sterilecotton swab. The test subjects brushed their teeth with a fluoridedental cream (see Table 1) for one minute with the toothbrush having theabove-noted tissue cleanser. Subsequently, the test subjects cleanedtheir tongue surface with a preferred construction of the tissueengaging elements 300 of the toothbrush 100 for ten seconds. Two hoursafter the cleaning of the tongue surface, a tongue bacteria sample wastaken from a side of the back of the tongue with a cotton swab. In theillustrative example, use of the tissue engaging elements controlledmore odor causing tongue bacteria than simply brushing the teeth alone.Use of the tissue cleanser 300 demonstrated a tongue bacteria logreduction of over 0.8 Log colony forming units/ml two hours after use onthe tongue.

EXAMPLE 3

In another study of the above-noted toothbrush, a MTT assay was used toexamine the viability of the epithelial cells collected from the oralcavity prior to and after the use of the toothbrush with the notedtissue cleanser. The MTT Assay was based on the enzymatic reduction ofthe tetrazolium salt MTT [3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl-tetrazoliumbromide+++] in living,metabolically active cells. The reaction was carried out in situ in testtubes, and the reaction product, a purple-colored formazan soluble indimethylsulfoxide, was measured colormetrically using a multiwell platereader. Advantageously, the MTT Assay offers a high degree of precision,ease of use, and suitability for the purpose for large scalechemosensitivity testing.

Following a 7-day washout period, the test subjects reported to a testsite without prior eating, drinking, or performing oral hygiene. Thetest subjects provided salivary rinse samples by rinsing their oralcavity with 9 ml of sterile water for 10 seconds and then dischargingthe water from the rinse into a tube containing 10* sterile phosphatebuffered saline(PBS) solution. The samples were refrigerated forapproximately 30 minutes before the MTT Assay was run. The test subjectsbrushed their teeth under supervision for one minute using a fluoridedental cream (see Table 1) followed by 10 seconds of tongue cleaningwith the tongue cleanser 300 of the preferred construction.Approximately 30 minutes after brushing and tongue cleaning, the testsubjects provided a rinse sample in the manner described previously.

The pre-rinse samples and post-rinse samples were centrifuged for 15minutes at about 3000 RPM. The supernatant, e.g., clear liquid, wasremoved and the pellet was resuspended in 2.5 mL of PBS. The sampleswere vortexed for 5 seconds, then 2.5 ml of MTT Solution was added. Thesamples were subsequently incubated in a gently shaking waterbath set at37[deg.] C. for 2 hours. Following the 2 hour incubation period, thesamples were centrifuged for 15 minutes at about 3000 RPM. Thesupernatatant was siphoned out and 3 mL of detergent (0.04 N AcidIsopropanol) was added to dissolve purple crystals. An increase ordecrease in MTT conversion was spectrophotometrically quantified. Fromeach sample, 200 [mu]l of each was added to 96 well plates and theoptical density was measured at 570 nm and compared to a negative buffercontrol. In the illustrative example, one minute of brushing followed by10 seconds of use of the tissue cleanser reduced oral epithelial cellsabout 72% as determined by a MTT assay protocol.

EXAMPLE 4

In another study, human test subjects provided baseline VSC samples viaa Halimeter™ (i.e., a sulfide meter). A Halimeter™ uses anelectrochemical, voltammetric sensor which generates a signal when it isexposed to VSC such as, sulfide and mercaptan gases and measures theconcentration of hydrogen sulfide gas in parts per billion. The testsubjects brushed their teeth under supervision for one minute with thepreferred construction of a toothbrush having the above noted tissuecleanser. Then, the test subjects used the noted toothbrush to providesix strokes on the tongue surface. A subsequent VSC sample was takenfrom the test subjects two hours after the brushing stage. In thisillustrative example, use of a toothbrush with the tissue cleanserreduced the measured VSC in the mouth odor over 35% from a baselinemeasured two hours after use.

EXAMPLE 5

In one other study, after a washout period, human test subjects rinsedtheir mouths with sterile water to provide a baseline sample for viableepithelial cell analysis with the MTT assay. The subjects brushed theirteeth under supervision for one minute with the preferred constructionof the toothbrush having the above-noted tissue cleanser. Then, the testsubjects used the tissue cleanser to provide six strokes on the tonguesurface. The test subjects provided a post rinse sample for analysis.The samples were tested and analyzed in the manner as discussed withrespect to Example 3. In this example, use of the toothbrush reducedoral epithelial cells by about 92% from a baseline as determined by MTTassay protocol.

In the above noted examples, the subjects brushed their teeth using afluoride dental cream with the formulation in Table 1.

TABLE 1 % wt. Ingredient 48.76%  Dicalcium Phosphate Dihydrate22.0063%   Water 22.00%  Glycerin 4.138%  SO3 Sodium Laurl Sulfate base−29% 1.000%  Sodium CMC-7MF-Food Grade 0.89% 105 Dental Cream Flavor0.76% Sodium Monoflurophosphate 0.25% Tetrasodium Pyrophosphate 0.20%Sodium Saccharin

As used throughout, ranges are used as shorthand for describing each andevery value that is within the range. Any value within the range can beselected as the terminus of the range. In addition, all references citedherein are hereby incorporated by referenced in their entireties. In theevent of a conflict in a definition in the present disclosure and thatof a cited reference, the present disclosure controls.

What is claimed is:
 1. An oral care implement comprising: a head and ahandle; a plurality of tooth cleaning elements extending from a firstface of the head; a receiving cavity formed into a second face of thehead opposite the first face; and a soft tissue cleanser formed of anelastomeric material positioned within the receiving cavity, the softtissue cleanser comprising a base surface that is flush with the secondface of the head and a plurality of projections extending beyond thesecond face of the head.
 2. The oral care implement of claim 1 whereinthe plurality of projections comprise a plurality of nubs.
 3. The oralcare implement of claim 2 wherein the plurality of nubs are conicallyshaped.
 4. The oral care implement of claim 2 wherein the head has alongitudinal axis and wherein the plurality of nubs are arranged inlongitudinal and transverse rows, and wherein adjacent longitudinal andtransverse rows are staggered.
 5. The oral care implement of claim 1wherein the tooth cleaning elements comprise bristles.
 6. The oral careimplement of claim 1 wherein the base surface and the plurality ofprojections are exposed.
 7. The oral care implement of claim 1 whereinthe soft tissue cleanser is injection molded into the receiving cavityto bond the soft tissue cleanser to the head.
 8. An oral care implementcomprising: a head and a handle; a plurality of tooth cleaning elementsextending from a first face of the head; a receiving cavity formed intoa second face of the head opposite the first face, the receiving cavitycomprising a floor and a sidewall extending substantially perpendicularfrom the floor; and a soft tissue cleanser formed of an elastomericmaterial that is injection molded into the receiving cavity to bond thesoft tissue cleanser to the head, the soft tissue cleanser comprising aplurality of projections extending beyond the second face of the head.9. The oral care implement of claim 8 wherein the receiving cavity has agenerally oval shape that corresponds to a shape of the head.
 10. Anoral care implement comprising: a head and a handle; a plurality oftooth cleaning elements extending from a first face of the head; areceiving cavity formed into a second face of the head opposite thefirst face; and a soft tissue cleanser formed of an elastomeric materialthat is injection molded into the receiving cavity to bond the softtissue cleanser to the head, the soft tissue cleanser comprising atleast one aperture extending therethrough.
 11. The oral care implementof claim 10 wherein the soft tissue cleanser further comprises a basehaving a front surface and an opposing rear surface, the at least oneaperture formed through the front and rear surfaces of the base.
 12. Theoral care implement of claim 10 wherein the soft tissue cleanser furthercomprises a plurality of projections extending beyond the second face ofthe head.
 13. The oral care implement of claim 12 wherein the pluralityof projections comprise a plurality of nubs.
 14. The oral care implementof claim 13 wherein the plurality of nubs are conically shaped.
 15. Theoral care implement of claim 10 wherein the at least one aperture isaligned along a longitudinal axis of the head.
 16. The oral careimplement of claim 15 further comprising a plurality of the aperturesaligned along the longitudinal axis of the head.
 17. The oral careimplement of claim 10 wherein the receiving cavity has a generally ovalshape that corresponds to a shape of the head.